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Novo Nordisk A/S

About Novo Nordisk supports secondary use of data from Novo Nordisk-sponsored clinical studies for conducting further legitimate scientific research as set out in the joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing.
How we share on the Vivli Platform As a data access requestor, you can submit a scientific research proposal which documents the legitimacy of your research project and the qualifications of your research team using the Vivli request form.

More information is available on Novo Nordisk Trials.
Anonymization Standards   The following data protection procedures for personally identifiable information are performed by Novo Nordisk prior to data sharing:

  • Patient identifiers (subject number): Replaced by a new patient ID, consistently across all datasets to keep the patient-record relationship
  • Further unique identifiers (kit numbers, devices, etc.): Suppressed
  • Site ID: Replaced by a new site ID or suppressed
  • Date of birth: Suppressed
  • Sex: Retained or suppressed
  • Age: Replaced with age group or suppressed
  • Race and Ethnicity: Suppressed or retained
  • Country: Replaced with continent or retained or suppressed
  • BMI: Replaced with groups or suppressed
  • Height/Weight: Suppressed or replaced with groups
  • Dates/Times related to study subject: Dates shifted by randomized date offset, time left unchanged
  • Comments, free text, variables containing personally identifiable information (PII), e.g., names, initials: Suppressed
  • Verbatim term of adverse events and medical history: Verbatim terms are suppressed; some dictionary coded terms are retained while others are suppressed
  • Verbatim term of concomitant medications: Verbatim terms are suppressed; dictionary coded terms are mostly retained

Where multiple options are available, the choice of rules to be applied is determined by the risk assessment to achieve the required risk threshold while retaining maximum utility of data. For further details regarding the anonymization process, please write to DataAccess@novonordisk.com.
Studies Listed for Sharing Access to anonymized individual participant‑level data and redacted study documents may be requested for Novo Nordisk‑sponsored phase 2–4 studies with study start after January 2014, provided that results tables have been posted on ClinicalTrials.gov and the product’s indications are approved for marketing in Novo Nordisk’s major markets.

Studies not found in the Vivli search list can be requested via the Vivli Platform, sharing of these will be considered on a case-by-case basis.
Exceptions Novo Nordisk may choose to reject data access requests if:

  • The Data Request is not seeking access to anonymized participant-level data
  • Data sharing is prohibited by the patient information/patient informed consent, legal or regulatory requirements, or contractual constraints on data sharing
  • The requested study does not contain the data necessary to answer the scientific question proposed by the research or the requested data is not appropriate for the research proposal
  • The requested data has not been collected for the purpose of the study but can only be derived from samples collected for future analyses
  • The Data Request’s project aim is commercial or litigious
  • The Data Request is Out of Scope (see ‘Studies listed for sharing’)
  • The requested data is unavailable
  • The data cannot be anonymised sufficiently
  • The data requested cannot be shared due to ongoing regulatory activities
  • The request proposal competes with internal business critical research activities or publication plans
  • Commercially confidential information and/or Novo Nordisk IP rights cannot be protected sufficiently
  • There is a potential or actual conflict of interest, or potential competitive risk
Questions or enquiries Questions and enquiries can be sent to the Novo Nordisk Data Access Team at DataAccess@novonordisk.com.
When studies are available for sharing Novo Nordisk will review the list of studies bi-annually and add studies which meet the above-mentioned criteria as they become available.
Review Criteria for Data Requests All data requests are reviewed to ensure that data sharing is lawful, ethical and feasible according to Novo Nordisk internal guidance. The review includes, but is not limited to:

  • Data availability
  • There is a legal basis for sharing the requested data for secondary purposes
  • Anonymization is feasible, e.g. size of the dataset, special populations, rare diseases
  • Vulnerable populations can be protected
  • The proposed research does not have a commercial purpose
  • Novo Nordisk commercially confidential information and IP rights can be protected
  • The request proposal does not conflict with internal business critical research activities or publication plans
Additional Conditions for Access Research teams must have relevant qualifications to conduct the proposed research project and include a biostatistician.
Data Request Review Process Data requests will be reviewed internally and must be approved according to established Novo Nordisk governance frameworks. Upon approval by Novo Nordisk, data sharing requests and research proposals will be reviewed by the Vivli Independent Review Panel.
What information will be provided Novo Nordisk shares anonymized study participant-level data, redacted study protocols, and a description of the data set.

Upon specific request Novo Nordisk can provide redacted Core CSRs (excluding section 14) and empty CRFs.
Access to study documents without participant-level data Novo Nordisk makes CSR Synopsis available on Novo Nordisk Trials.

Clinical Study protocols and Statistical Analysis Plans are uploaded to ClinicalTrials.gov together with results tables. Additionally, Clinical Document Packages per Health Canada’s PRCI and EMA’s Policy 0070 are disclosed on agency controlled websites.
Clinical Study Register or Website https://www.novonordisk-trials.com/
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